Code of Maryland Regulations (Last Updated: April 6, 2021) |
Title 10. Maryland Department of Health |
Part 4. |
Subtitle 34. BOARD OF PHARMACY |
Chapter 10.34.35. Infusion Pharmacy Services in an Alternate Site Care Environment |
Sec. 10.34.35.06. Minimum Requirements for Policies and Procedures
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The policies and procedures shall:
A. Be congruent with State regulations and standards of care from accrediting bodies and professional organizations; and
B. Address:
(1) Personnel:
(a) Training and Orientation;
(b) Duties; and
(c) Qualifications;
(2) Security of the facility;
(3) Standards of patient care;
(4) Infection control;
(5) Initial and ongoing home safety assessments;
(6) The provision of patient or caregiver education including, but not limited to:
(a) Drug and therapy administration-specific information and precautions;
(b) Reporting adverse drug reactions;
(c) Reporting side effects;
(d) Infusion pharmacy contact information;
(e) Emergency measures related to:
(i) Changes in patient condition requiring medical intervention; and
(ii) Events which may delay or prevent delivery of pharmaceuticals or nursing care; and
(f) Equipment use and safety.
(7) Patient care operations, including but not limited to:
(a) If applicable, pharmacist checking procedures related to order entry and compounding accuracy;
(b) Therapy-specific monitoring parameters for:
(i) Laboratory testing;
(ii) Appropriate frequency of testing; and
(iii) Patient follow-up; and
(c) Pump, or other patient-use equipment, between-patient cleaning, testing, and preventive maintenance, which include specific:
(i) Procedures and documentation of cleaning, testing and preventive maintenance for patient equipment according to manufacturers guidelines; and
(ii) Frequencies for all equipment maintenance activities;
(8) Delivery arrangements;
(9) Patient confidentiality and the Health Insurance Portability and Accountability Act, 45 CFR Parts 160 and 164; and
(10) Availability of a pharmacist on call after-hours to respond to:
(a) Pharmacy related patient or caregiver inquiries; and
(b) Medication or supply needs.